Covance, a $15 billion Fortune 500 company, with operations in over 97 countries, has led the way in improving patient outcomes through visionary data sciences over the last five decades. We have supported 100% of the top 50 drugs in the market and all the oncology medicines approved in 2016. Our team of over 57,000 across the globe is committed to advancing healthcare and bringing new medicines to market sooner. Our unique perspectives, built from decades of scientific expertise and precision delivery, help our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Driven by a passion for excellence and a relentless commitment to quality, we unlock opportunities that advance innovation and deliver the promise of a healthier world.
Post : Associate QA Director
Job Description
• Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines, and fulfill client and Covance requirements.
• Assure that all projects for which Global QA Lead responsibilities have been assigned have an audit strategy agreed and documented in the QA&C central planning system.
• Manage allocation of QA&C staff within local region to complete the required audits and fulfill staff utilization/achievement of QA&C targets
• Assure that audits as defined in the global audit plan are completed on time and within budget including reporting and follow up to closure.
• Provide local /regional leadership and line management as required.
Candidate Profile
• University/college degree, BA/BS (life science preferred) or equivalent experience Preferred
• Masters or other advanced degree (e.g. postgraduate qualification in Quality Assurance) or Equivalent experience
• Excellent technical knowledge, understanidng an experience applying ICH/FDA / Good Clinical Practices
• Strong analyticial skills
• Excellent oral, written and presentation skills
• Excellent planning and organizational skills
• Proven interpersonal skills
• Demonstrated ability to handle multiple competing priorities across clinical operating units
• Ability to inspire effective teamwork and motivate staff within a matrix system
• Ability to function as a member of a global clinical team
• Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process
• Financial understanding of global clinical development budgets
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Experience
• 4 years’ experience in Clinical Quality Assurance, preferably with GCP experience
• 7 years’ experience in other professional roles within pharmaceutical/CRO environment.. Other required work-related experiences
• Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
• Knowledge of the drug development process from the perspective of a contract research organization
Additional Information:
Experience : 4-7 years
Qualification : Graduate, Masters
Industry Type: Pharma
Functional Area: Quality Assurance
Job Number : 2018-18715
End Date : 5th June, 2018
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